An observational study in Acute Kidney Injury and Acute Respiratory Distress Syndrome, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-11-06.
Sponsored by Zagazig University · Observational
Several studies suggested that ARDS may have important adverse effects on renal function, but few studies have specifically addressed the risk factors of AKI and its impact on the outcome in theses patients.
Acute respiratory distress syndrome is considered an acute diffuse lung injury in which an inciting inflammatory event is followed by hypoxemic respiratory failure. Despite advances in the management of ARDS, the mortality remains high. The LUNG SAFE study reported that hospital mortality was 34.9% in patients with mild ARDS, 40.3% in patients with moderate ARDS, and 46.1% in patients with severe ARDS. Understanding the prognostic factors in ARDS is essential for decreasing its mortality. Acute kidney injury (AKI) is a common and challenging medical condition in critically ill patients, in which there is a sudden renal impairment during hours to days and it is known to be associated with increased mortality .Other adverse outcomes associated with AKI includes chronic kidney disease (CKD) and high cardio-vascular complications. The incidence of AKI in hospitalized adults was reported to be 22% with a mortality rate of 24%. The severity of AKI ranges from stage 1 to stage 3 according to The KDIGO (Kidney Disease: Improving Global Outcomes) system, based on decreased urine output over time, or increases in serum creatinine, or both.
1,596 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 81 is below the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
81 ARDS patients admitted to the Respiratory, Surgical and Internal Medicine Intensive Care unit, Zagazig University Hospitals during the period from September 2017 to March 2019
Exclusion Criteria:
ARDS patients were followed for the development of AKI during their ICU stay
Diagnostic Test: kidney function tests - urine output
AKI was classified based on the worst of either creatinine or urine output criterion as follows: Stage I 1.5-1.9 times baseline OR ≥0.3 mg/dl increase in the serum creatinine, OR urine output \<0.5 ml/kg per hour for 6 to 12 hours. Stage II 2.0-2.9 times baseline increase in the serum creatinine OR urine output \<0.5 ml/kg per hour for ≥12 hours. Stage III 3.0 times baseline increase in the serum creatinine OR increase in serum creatinine to ≥4.0 mg OR urine output of \<0.3 ml/kg per hour for ≥24 hours, OR anuria for ≥12 hours OR the initiation of renal replacement therapy.
development of AKI
AKI was classified based on the worst of either creatinine or urine output criterion as follows: Stage I 1.5-1.9 times baseline OR ≥0.3 mg/dl increase in the serum creatinine, OR urine output \<0.5 ml/kg per hour for 6 to 12 hours. Stage II 2.0-2.9 times baseline increase in the serum creatinine OR urine output \<0.5 ml/kg per hour for ≥12 hours. Stage III 3.0 times baseline increase in the serum creatinine OR increase in serum creatinine to ≥4.0 mg OR urine output of \<0.3 ml/kg per hour for ≥24 hours, OR anuria for ≥12 hours OR the initiation of renal replacement therapy.
Time frame: 30 days
ICU length of stay.
development of AKI affects the ICU stay
Time frame: 30 days
hospital length of stay.
development of AKI may affect the length of stay in hospital
Time frame: 90 days
Hospital mortality
the effect of development of AKI on the mortality of ARDS patients
Time frame: 90 days
Plan to share: Yes — All collected IPD
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
Zagazig University